CIR Reaches Verdicts on Butyl Myristate, HC Red No. 3 and More

Posted: June 17, 2008

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In order to create a comprehensive document containing data that will adequately document the safety of this group of chemicals, the panel tabled further discussion to allow inclusion of ammonium laureth sulfate and sodium laureth sulfate in this report.  Interested parties are encouraged to provide any relevant data on these two additional ingredients. The panel will review a revised draft at its September 22-23 meeting.

4. New high priority ingredient identified - Chlorphenesin
Based on ongoing concern about potential adverse effects in infants exposed to chlorphenesin that had been used in nipple creams, the FDA requested that CIR undertake a safety assessment. The CIR Expert Panel agreed to add this to the high priority list. In addition to assessing the safety of chlorphenesin in cosmetics, such a review should also address the potential use of chlorphenesin carbamate in cosmetics. Currently, chlorphenesin carbamate is considered to be a drug.

5. Ongoing re-reviews
CIR staff will gather any new safety test data from the open scientific literature, FDA will provide current uses as a function of product category, and industry will conduct surveys to determine current use concentrations for the listed safety assessments and present the information to the CIR Expert Panel at the Sept. 22-23, 2008, meeting. The CIR also will prepare a table that lists other cosmetic ingredients that appear to be chemically related to the above named ingredients so that the CIR Expert Panel may determine if the safety of any additional ingredients are supported by the existing safety assessment.

Sodium dodecylbenzenesulfonate, TEA-dodecylbenzenesulfonate, and sodium decylbenzenesulfonate
CIR is considering that the data in the original safety assessment of these three ingredients may support the safety of an additional ingredients: ammonium dodecylbenzenesulfonate, calcium dodecylbenzenesulfonate, deadodecylbenzenesulfonate, isopropylamine dodecylbenzenesulfonate, magnesium isodecylbenzenesulfonate, mipadodecylbenzenesulfonate, potassium dodecylbenzenesulfonate, sodium tridecylbenzenesulfonate and teatridecylbenzenesulfonate, ethyl ester of PVM/MA copolymer and butyl ester of PVM/MA copolymer. The CIR is considering that the data in the original safety assessment may support the safety of calcium/sodium PVM/MA copolymer, isopropyl ester of PVM/MA, potassium ethyl ester of PVM/MA copolymer, potassium butyl ester of PVM/MA copolymer, PVM/MA copolymer, sodium ethyl ester of PVM/MA copolymer, and sodium butyl ester of PVM/MA copolymer.

Sesame oil
The CIR is considering that the data in the original safety assessment may support the safety of additional ingredients:  Hydrogenated sesame seed oil; hydrolyzed sesame extract, hydrolyzed sesame protein, sesame amino acids, sesame oil glycereth-8 esters, sesame oil polyglyceryl-6 esters, Sesamum indicum (sesame) oil unsaponifiables, Sesamum indicum (sesame) seed, Sesamum indicum (sesame) seed extract, Sesamum indicum (sesame) seed powder, and Sesamum indicum (sesame) sprout extract, and sodium sesameseedate.